Prevention of Contrast-induced Nephropathy in Patients With Acute Myocardial Infarction
1 other identifier
interventional
720
1 country
1
Brief Summary
OBJECTIVE: To evaluate the efficacy of prevention of contrast induced nephropathy in patients with ST segment elevation myocardial infarction treated with primary percutaneous coronary intervention. DESIGN: Prospective study. SETTING: Three-center study Acute kidney injury was defined as a rise in creatinine \>25% from baseline Serum creatinine will be measured at baseline and each day for the following 3 days and at 30 days. Patients will be randomised to:
- 1.Standard treatment
- 2.Standard treatment + acetylcystein for 2 days
- 3.Standard treatment + Sodium bicarbonate 500 ml / followed by 100 ml/h for 5 hours
- 4.Standard treatment + acetylcystein for 2 days + Sodium bicarbonate 500 ml / followed by 100 ml/h for 5 hours
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2010
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2010
CompletedFirst Submitted
Initial submission to the registry
July 9, 2010
CompletedFirst Posted
Study publicly available on registry
July 12, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedMarch 22, 2013
March 1, 2013
2.9 years
July 9, 2010
March 21, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Prevention of contrast induced nephropathy in STEMI patients treated with primary PCI
Rise in creatinine \>25% from baseline to day 3
from baseline to day 3
Secondary Outcomes (1)
Prevention of contrast induced nephropathy in STEMI patients treated with primary PCI
from baseline to day 30
Study Arms (4)
Standard treatment
ACTIVE COMPARATORHydration
Combined Acetylcystein and Sodium Bicarbonat
ACTIVE COMPARATORSodium Bicarbonate
ACTIVE COMPARATORAcetylcystein for 2 days
ACTIVE COMPARATORStandard treatment + acetylcystein for 2 days
Interventions
Sodium bicarbonate 500 ml followed by 100 ml/hour for 5 hours
Sodium bicarbonate 500 ml followed by 100 ml/hour for 5 hours combined with acetylcystein tablets for 2 days
Eligibility Criteria
You may qualify if:
- STEMI patients treated with primary PCI
You may not qualify if:
- Cardiogenic shock
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Odense University Hospital
Odense, 5000, Denmark
Related Publications (1)
Thayssen P, Lassen JF, Jensen SE, Hansen KN, Hansen HS, Christiansen EH, Junker A, Ravkilde J, Thuesen L, Veien KT, Jensen LO. Prevention of contrast-induced nephropathy with N-acetylcysteine or sodium bicarbonate in patients with ST-segment-myocardial infarction: a prospective, randomized, open-labeled trial. Circ Cardiovasc Interv. 2014 Apr;7(2):216-24. doi: 10.1161/CIRCINTERVENTIONS.113.000653. Epub 2014 Apr 8.
PMID: 24714489DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Per Thayssen, MD DMSci
Odense University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD DMSci PhD
Study Record Dates
First Submitted
July 9, 2010
First Posted
July 12, 2010
Study Start
April 1, 2010
Primary Completion
March 1, 2013
Study Completion
March 1, 2013
Last Updated
March 22, 2013
Record last verified: 2013-03